NIH Selects Biopharma's Lead Asset for Commercialization Accelerator Program

A Maxim Group analyst reported on news and upcoming catalysts for this late-stage drug developer.

In a Sept. 13 research note, Maxim Group analyst James McCarthy reported the National Institutes of Health (NIH) chose Soligenix Inc.'s ( (SNGX):NASDAQ) lead candidate SGX942 (dusquetide) for oral mucositis in head-and-neck cancer for its Small Business Innovation Research/Small Business Technology Transfer Commercialization Accelerator Program (CAP) for 2018-2019.

In the nine-month CAP, companies get help developing and carrying out plans and efforts for commercialization of a new technology. Assistance includes input from industry, investment and regulatory experts.

SGX492 is an innate defense regulator with fast-track designation, McCarthy reiterated. It is currently being evaluated in DOM-INNATE, a Phase 3 pivotal trial for oral mucositis in patients with head-and-neck cancer who are receiving chemoradiation therapy. The primary endpoint is median duration of severe oral mucositis, which will be assessed by an examination at every treatment visit and for six subsequent weeks after treatment is completed.

Interim results from the study are anticipated in H1/19, with topline results to follow in H2/19. "Note that a positive Phase 3 will also be sufficient for approval by the European Medicines Agency," McCarthy added.

In the meantime, Soligenix is expected to release interim data from its Phase 3 FLASH study of SGX301, a topical synthetic hypericin, this October. From the U.S. Food and Drug Administration, the therapeutic has fast-track and orphan drug designations; from the EMA it has an orphan drug designation; and from the United Kingdom's Medicines and Healthcare products regulatory agency it has promising innovative medicine status.

In FLASH, which is in progress, SGX301 is being evaluated as a first-line treatment for cutaneous T cell lymphoma. The primary endpoint is partial or complete response of lesions, when compared to the baseline, on evaluation in week eight. Topline results should read out in H1/19.

Also slated for release in H2/18 are additional preclinical data from a third Soligenix drug, RiVax, an anti-ricin toxin vaccine with orphan drug status. Further, two Phase 2 trials are scheduled to start this year, one in animals, one in humans. "The approval pathway for RiVax," McCarthy explained, "will be via the two animal rule, animal toxin exposure for efficacy combined with healthy subject human immunogenicity data."

Maxim has a Buy recommendation and a $4 per share 12-month price target on Soligenix, whose stock is trading now around $1.65 per share.

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Disclosures from Maxim Group, Soligenix Inc., Sept. 13, 2018

I, Jason McCarthy, Ph.D., attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.

I, Caroline Palomeque, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.

The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firm's total revenues, a portion of which is generated by investment banking activities.

Maxim Group makes a market in Soligenix Inc.

Maxim Group expects to receive or intends to seek compensation for investment banking services from Soligenix Inc. in the next 3 months.

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